Registration Dossier
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EC number: 203-815-1 | CAS number: 110-91-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January 20-23, 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was performed according to OECD 404 guideline. GLP compliant. There were no significant deviations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report Date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- test control not performed
- GLP compliance:
- yes (incl. certificate)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material: Morpholine
- Physical state: clear colorless liquid
- Lot/batch No.: B-1-20
- Purity test date: responsibility of the Sponsor
- Stability under test conditions: responsibility of the Sponsor
- Other:amount submitted: 668.38g (test article and container)/pH:8 (paper indicator)
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Covance,The Development Services Company, Denver, PA, USA
- Age at study initiation: 19-21 weeks
- Weight at study initiation: 2.710-3.278 kg
- Housing: rabbits were housed individually in stainless steel cages
- Diet: PMI Certified Lab Rabbit HF Diet
- Water: fresh water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 16-21°C
- Humidity: 25-70 %
- Photoperiod: 12 hours light/12 hours dark
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL/site - Duration of treatment / exposure:
- 3 min
- Observation period:
- 3 and 55 min
- Number of animals:
- 6 animals (3 males, 3 females)
- Details on study design:
- TEST SITE
- Area of exposure: dorsal area of the trunk (clipped free of fur)
REMOVAL OF TEST SUBSTANCE
- Washing: no data
- Time after start of exposure: 3 min
SCORING SYSTEM:
Draize Evaluation of Dermal Irritation
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 2/6
- Time point:
- other: immediate after exposure
- Score:
- >= 2
- Max. score:
- 4
- Remarks on result:
- other: well-defined erythema
- Irritation parameter:
- erythema score
- Basis:
- animal: 4/6
- Time point:
- other: immediate after exposure
- Score:
- >= 1
- Max. score:
- 4
- Remarks on result:
- other: very slight erythema
- Irritation parameter:
- edema score
- Basis:
- animal: 3/6
- Time point:
- other: immediate after exposure
- Score:
- >= 1
- Max. score:
- 4
- Remarks on result:
- other: very slight edema
- Irritation parameter:
- edema score
- Basis:
- animal: 3/6
- Time point:
- other: immediate after exposure
- Score:
- >= 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal: 6/6
- Time point:
- other: 55min
- Score:
- >= 4
- Max. score:
- 4
- Remarks on result:
- other: severe erythema, necrosis
- Irritation parameter:
- edema score
- Basis:
- animal: 6/6
- Time point:
- other: 55min
- Score:
- >= 4
- Max. score:
- 4
- Remarks on result:
- other: severe edema, necrosis
- Irritant / corrosive response data:
- In all animals severe etyhema, severe oedema and necrosis was observed after 55 min.
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: other: DOT Classification (Packaging group I)
- Conclusions:
- Morpholine was considered to be a severe irritant. The test article was considered corrosive according to the DOT Classification (Packaging group I).
- Executive summary:
In this primary dermal irritation study (Huntsman, 1997), 0.5 mL of Morpholine was applied to one site on the clipped dorsal trunk of 6 New Zealand White rabbits (3 males and 3 females) for an exposure period of 3 minutes. Observations for responses were recorded immediately after unwrap and at 55 minutes. Grading of irritation was performed according to the method of Draize. Following an exposure period of 3 minutes, severe erythema, severe oedema and necrosis were observed. Therefore, Morpholine was considered to be a severe irritant and was considered as corrosive according to DOT classification (Packaging group 1).
This study is classified as acceptable. It satisfies the requirements of OECD test guideline 404.
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